- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00739986
Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo (CD04)
A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment vs. Placebo
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brussels, Belgium
- Cliniques Universitaires Saint-Luc
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Leuven, Belgium
- Academic Hospital Gasthuisberg
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Berlin, Germany
- Benjamin Franklin University
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Hannover, Germany
- Medizinischen Hochschule-Hannover
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Heidelberg, Germany
- Universitats Klinikum Heidelberg
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Kiel, Germany
- University of Kiel
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Minden, Germany
- Gastroenterologische Fachpraxis
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Muenster, Germany
- University of Münster
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Munchen, Germany
- Stadtisches Krankenhaus Munchen-Bogenhausen
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Haifa, Israel
- Rambam Medical Center
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Jerusalem, Israel
- Hadassah Medical Center
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Jerusalem, Israel
- Shaare Zedek Hospital
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Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center
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Tel Hashomer, Israel
- Chaim Sheba Medical Center
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Amsterdam, Netherlands
- Academic Medical Center
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Amsterdam, Netherlands
- Free University (Vrije Universiteit)
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Maastricht, Netherlands
- Academisch Ziekenhuis Maastricht
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Rotterdam, Netherlands
- Erasmus Medical Center
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California
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San Diego, California, United States, 92120
- Institute of Healthcare Assessment
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San Francisco, California, United States, 94115
- University of California, San Francisco
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Georgia
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Atlanta, Georgia, United States, 30342
- Atlanta Gastroenterology Associates
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Suwanee, Georgia, United States, 30024
- Advanced Gastroenterology Associates
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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New York
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Great Neck, New York, United States, 11021
- Long Island Clinical Research Associates
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New York, New York, United States, 10128
- Asher Kornbluth, MD
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Rochester, New York, United States, 14621
- Rochester General Hospital
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Tennessee
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Bristol, Tennessee, United States, 37620
- Gastroenterology Associates
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Kingsport, Tennessee, United States, 37660
- Gastroenterology Associates
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women at least 18 years of age.
- Baseline Crohn's Disease Activity Index (CDAI) 250-400.
- Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
- Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:
- those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving more than 25 mg/wk
- those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
- those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving more than 20 mg/day prednisone or equivalent
- those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
- those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
- Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
The screening laboratory tests were to meet the following criteria:
Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)
- Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
- Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.
Exclusion Criteria:
- Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
- History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
- Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
- Patients with any ostomy, extensive bowel resection (e.g., more than 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
- Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
- Patients with known severe fixed symptomatic stenosis of the small or large intestine.
- Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
- Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
- Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
- Patients with previous diagnosis of, or known, malignancies.
- Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
- History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
- Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
- Women who were pregnant or breast-feeding.
- A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
- Patients who had received CNI-1493 in the past.
- More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Semapimod 60 mg IV x 1 day, placebo IV x 2 days
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semapimod 60 mg IV x 1 day, placebo x 2 days
Semapimod 60 mg IV x 3 days
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Experimental: 2
Semapimod 60 mg IV x 3 days
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semapimod 60 mg IV x 1 day, placebo x 2 days
Semapimod 60 mg IV x 3 days
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Placebo Comparator: 3
Placebo comparator IV x 3 days
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placebo IV x 3 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Crohn's Disease Activity Index (CDAI) score
Time Frame: Day 29
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Day 29
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: Day 29
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Day 29
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Crohn's disease endoscopic index of severity (CDEIS)
Time Frame: Day 29
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Day 29
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Change in level of C-reactive protein (CRP)
Time Frame: Day 29
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Day 29
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Safety (Adverse events)
Time Frame: Days 29 and 57
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Days 29 and 57
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daan Hommes, MD, Academic Medical Center, Netherlands
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Crohn Disease
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Semapimod
Other Study ID Numbers
- CNI-1493-CD04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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